Ciclosporin A and Acute Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ciclosporine A
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction
Eligibility Criteria
Inclusion Criteria:
- Male and female patients, aged more than 18, with suspected first acute myocardial infarction
- Within 12 hours of the onset of chest pain
- With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.
Exclusion Criteria:
- Hypersensibility to ciclosporine A
- Cardiac arrest or cardiogenic shock
- Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
- Known renal failure or serum creatinine > 120 µmole/l at admission
- Liver failure
- Uncontrolled hypertension
- Current pregnancy or women without contraception
Sites / Locations
- Michel Ovize
Outcomes
Primary Outcome Measures
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary Outcome Measures
Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
No reflow evaluated by MRI at day 5
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
Full Information
NCT ID
NCT00403728
First Posted
November 24, 2006
Last Updated
April 26, 2007
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00403728
Brief Title
Ciclosporin A and Acute Myocardial Infarction
Official Title
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
Brief Summary
Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ciclosporine A
Primary Outcome Measure Information:
Title
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary Outcome Measure Information:
Title
Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
Title
No reflow evaluated by MRI at day 5
Title
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients, aged more than 18, with suspected first acute myocardial infarction
Within 12 hours of the onset of chest pain
With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.
Exclusion Criteria:
Hypersensibility to ciclosporine A
Cardiac arrest or cardiogenic shock
Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
Known renal failure or serum creatinine > 120 µmole/l at admission
Liver failure
Uncontrolled hypertension
Current pregnancy or women without contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Ovize, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michel Ovize
City
Lyon
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20298926
Citation
Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.
Results Reference
derived
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Ciclosporin A and Acute Myocardial Infarction
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